Part II: Exercise in Hispanic Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 53
- 试验地点
- 4
- 主要终点
- Changes in Exercise Behavior and Energy Expenditure
研究概览
简要总结
The goal of this research study is to test an exercise program that is designed for Hispanic breast cancer survivors. Researchers want to learn the most effective strategies for promoting exercise.
详细描述
Study Summary:
If you are found to be eligible to take part in this study, you will come in for 2 visits to complete fitness testing and questionnaires at the Behavioral Research Treatment Center (BRTC) at MD Anderson. During the week before your first visit to the BRTC, you'll wear an accelerometer at home. An accelerometer is a small device that you wear on your waist during the day. It records how active you are. The accelerometer will be mailed to you or given to you in clinic ahead of time by a staff member. You will bring the accelerometer with you to your first visit to the BRTC. This will be repeated at the end before your follow-up assessment visit. The visits should last about 2 hours and 30 minutes. You will be asked to exercise about 3-5 times every week for 16 weeks at home for at least 30 minutes. You will also be invited to group exercise sessions every month. You should attend at least 2 of these sessions. A family member or friend is invited to attend the group sessions with you. Six (3) months after the follow-up visit, you will complete follow-up questionnaires.
Study Visits:
At the baseline (first) visit, your blood pressure, heart rate, height, and weight will be measured. Your waist and hip will be measured. A tool that measures your skin thickness will be used on the back of your arm, above your hip, and on your thigh. Your arms will be measured by placing your arm in a tool used for measuring arm volume.
You will complete questionnaires about your demographic information (such as your age), medical history, any drugs you may be taking, your current level of physical activity, your quality of life, and your environment and exercise (such as how many people you see exercising daily). The questionnaires should take about 35 minutes to complete. You may complete these questionnaires either when you sign the informed consent form or at your first visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Be Female and be 21 years of age or older. (Pilot Test and PreTest Criteria)
- •Self-reported Mexican-American ( for Mexican-American participants) or Puerto Rican ethnicity. (Pilot Test and PreTest Criteria)
- •History of breast cancer (invasive or ductal carcinoma in situ). (Pilot Test Criteria only)
- •At least 3 months post treatment (surgery, chemotherapy, radiation). (Pilot Test Criteria only)
- •Not meeting current recommended physical activity guidelines. (Pilot Test and PreTest Criteria)
- •Able to read/write in either English or Spanish. (Pilot Test and PreTest Criteria)
- •Reside in Harris County, Texas or one of the contiguous counties or metropolitan area of San Juan, Puerto Rico. (Pilot Test and PreTest Criteria)
- •Be able to provide informed consent. (Pilot Test and PreTest Criteria)
- •Be oriented to person, place, and time. (Pilot Test and PreTest Criteria)
排除标准
- •Currently receiving Herceptin or non-hormonal treatment for cancer (hormonal treatment is allowed). (Pilot Test and PreTest Criteria)
- •Present with any of American College of Sports Medicine's absolute contraindications to exercise testing: (A recent significant change in the resting ECG suggesting significant ischemia, recent myocardial infarction (within 2 days), or other acute cardiac event; unstable angina; uncontrolled cardiac dysrhythmias causing symptoms or hemodynamic compromise; symptomatic severe aortic stenosis; uncontrolled symptomatic heart failure; acute pulmonary embolus or pulmonary infarction; acute myocarditis or pericarditis; suspected or known dissecting aneurysm acute systemic infection, accompanied by fever, body aches, or swollen lymph glands). ( Pilot Test and PreTest Criteria)
结局指标
主要结局
Changes in Exercise Behavior and Energy Expenditure
时间窗: 6 months
Exercise behavior measured as frequency of exercise as assessed by the IPAQ score. Multiple linear regression used to test for differences in the changes between groups adjusting for relevant covariates, such as baseline activity level (IPAQ score) and BMI. Linear mixed model analysis also performed for weekly change in exercise behavior. The continuous score (MET minutes/week) used as primary physical activity outcome, measured at baseline and follow-up. Compliance measured using exercise logs, which will record resistance exercise and pedometer steps.
次要结局
- Effects of Behavioral Exercise Intervention on Biological Markers(16 weeks)